Clinical Document Specialist- I



Position responsibilities:

  • Responsible for QC and review of study documentation for Trial Master File (TMF) quality for sponsor and/or CRO studies.
  • Responsible for resolving queries of the QC1 and QC2 reviewers before they are escalated to the PM and senior document specialists.
  • Be proactive in researching eTMF or available resources to find answers to the queries of QC1 and QC2 reviewers.
  • Assist senior document specialists for conduction trainings for new joinees, re-training for team members as required on an ongoing basis.
  • Assist study leads to ensure smooth functioning of assigned projects from start to end.
  • Assist study leads for managing Q&As for assigned projects.
  • Coordinate with PMs for requirements of updates in system configurations or mapping documents.
  • Assist the PMs for client meetings or provide them required data on assigned projects as required by the clients.
  • Assist senior document specialists for performing internal audits.
  • Review audit plans before finalizing with the client and ensure the internal audits are performed as per Audit plan.
  • Perform random QC checks on assigned projects to ensure eTMF quality.
  • Come up with valuable suggestions for improving the processes and performances of fellow team members.
  • Be able to take up mentorship role for fellow team members as required.
  • Coordinate with all the team members across the globe and ensure that all the teams function in a similar way across a project to ensure consistency.
  • Assist with User Acceptance Testing during product development and release
  • Work on cross functional teams including Project Management, Business Development Client Services, Development and IT on the implementation and management of client projects
  • Gather and provide feedback on features and enhancements that may be needed on an ongoing basis to development team
  • Serve as part as the Project team on client projects
  • Participate and become an expert in the TMF Reference Model and stay current on regulatory changes
  • Become an expert in Trial Interactive features and functionality and work with GM, Life Sciences Solutions, Project Management and Development to recommend new features and functionality to improve the product and reduce manual activities
  • Respond to client requests for new project initiatives. Collaborate with various members of the production and sales teams to assess the scope of work and produce cost estimates.
  • Take a proactive role in learning about clients’ industry, business needs and company culture, educating the project team, identifying new business opportunities and providing a high level of service.
  • Set and fulfill client expectations.
  • Perform other special projects or duties when required.


Essential skills and experience required:

  • Minimum Bachelor’s Degree from a 4-year college or equivalent
  • Minimum of 4-6 years of experience in the life sciences industry
  • Previous employment in Pharmaceutical, CRO, Medical Device, Investigative Site or eTMF preferred
  • Experience with essential documents and other study documentation
  • Knowledge of clinical development phases and processes including GCP and ICH regulations
  • Superior written and spoken communication skills in English.
  • Experience in a leadership role preferred.
  • Proficiency in Microsoft Office (Word, Excel, Outlook), and knowledge of eClinical technologies
  • Proficiency in Document Management, (Adobe professional, knowledge of Scanning, indexing, using of ISI Tools and Capture Perfect)
  • Must be able multitask in a fast-paced environment, work well with people from a variety of different backgrounds and cultures, build relationships with clients and co-workers, work independently and as part of a team, take active measures to solve problems and commit to a high level of service




TransPerfect was founded in 1992 with the following mission: to provide the highest quality language services to leading businesses worldwide. With no external financing, the TransPerfect family of companies grew from its humble beginnings as a two-person company operating in an NYU business school dorm room into the world's third-largest translation and software localization firm and one of the fastest-growing privately held companies in the United States. With a network of over 5,000 language specialists and over 4,000 full-time employees in over 90 locations across 6 continents, we're continuously ready to meet our clients' needs, around the clock and around the world. 

For over 20 years, TransPerfect has assisted life sciences companies with global, regional, and country-level product launches. Offering multiple services and solutions customized to meet the needs of each brand, TransPerfect has helped the world’s leading pharmaceutical, biotechnology, and medical device companies successfully launch products throughout the world.


Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed